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临床试验/NCT04437797
NCT04437797Unknown不适用

Soft Tissue Outcomes of Badly Broken-down Teeth Treated With Surgical Extrusion Compared With Immediate Implant Placement: A Randomized Controlled Trial

Cairo University0 个研究点目标入组 26 人开始时间: 2020年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
26
主要终点
Soft tissue outcome

研究概览

简要总结

Many patients suffer from badly decayed anterior teeth mostly in young age, causing esthetics and functional issues. This may be due to more than cause as fights, contact sports, accidents and falls.

However; implant placement might not be the treatment of choice in some situations such as: medically compromised patients with absolute contraindications for implant placement or requiring extensive augmentation procedures, growing patients, patients with financial limitations, in addition to patients living in rural areas with no access for CBCT machines.

Moreover, clinicians must be aware of cost-to-benefit ratios when attempting to recommend a specific treatment modality, especially in patients having financial limitations.

Regarding the aforementioned conditions, surgical extrusion might be considered a cost-effective 'often overlooked' alternative compared to immediate single-tooth implant placement. Regarding healing time, cost, soft and hard tissue outcomes, surgical extrusion may be a good alternative yielding better soft tissue results as we preserve the natural tooth with the whole periodontium.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients at 20-40 years old and have no history of periodontal disease. (periodontally healthy patients)
  • Single rooted teeth; should be single with adjacent intact or restored neighboring teeth. More than one tooth may be included in the same arch.
  • More than 1:1 crown root ratio, so that the crown to root ratio is 1:1 after extrusion and restoration

排除标准

  • Badly broken-down teeth with active signs of infection.
  • Teeth with vertical root fracture.
  • Teeth with severely tapered root.
  • Diabetic patients, assessed by measuring glycosylated hemoglobin (HbA1c). Patients with an HbA1c level greater than 8 will be excluded.
  • Potentially uncooperative patients who are not willing to go through the proposed interventions.
  • Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day). 9
  • History of radiation therapy and/or chemotherapy to the head and neck, or bone augmentation to implant site.
  • Labial cortical bone fenestration diagnosed from CBCT.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems, emotional instability, and unrealistic esthetic demands.

结局指标

主要结局

Soft tissue outcome

时间窗: 12 months

Pink esthetic score: 0-1-2 scoring system, 0 being the lowest, 2 being the highest value

次要结局

  • Survival(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ismail Tarek Mansour

Principal Investigator

Cairo University

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